Senior Medical Writing Lead: Strategy & Submissions

Green Key Resources; Massachusetts; On-site; USD 150,000 - 210,000; Full time

Job summary

BioPharma seeks an Associate Director of Medical Writing to provide strategic and operational leadership for medical writing across clinical programs. The role combines hands-on writing with resource planning and matrix leadership to deliver high-quality regulatory documents aligned with program goals.

The ideal candidate will have an advanced degree and 8+ years in medical writing or related areas, with experience supporting NDA/BLA/MAA and IND submissions, and a proven ability to manage

Qualifications

• Advanced degree in a relevant discipline.
• 8+ years of medical writing, clinical research, or related experience.
• Experience supporting NDA/BLA/MAA, IND submissions, and other major regulatory filings.
• Ability to lead complex projects, plan and optimize resources, and manage competing priorities.
• Strong ability to work independently, navigate ambiguity, and mitigate risk.
• Broad scientific understanding across multiple therapeutic areas; neuroscience experience preferred.
• Excellent written and verbal communication skills, with proven collaboration across teams.

Responsibilities

• Accountable for medical writing deliverables across one or more clinical programs, ensuring aligned timelines, quality, and resourcing.
• Independently author and lead planning, review, comment resolution, and delivery of routine and complex clinical and regulatory documents.
• Lead or coordinate clinical content development for complex regulatory submissions, aligning messaging with regulatory strategy.
• Serve as the primary medical writing lead on program teams, identifying risks and driving issue resolution.
• Oversee outsourced writing support, set expectations, manage review cycles, and ensure inspection-ready quality.
• Contribute to department goals, including process improvements and adoption of new tools and technologies.

Skills

Medical Writing

Regulatory Submissions

Cross-functional Leadership

Resource Planning

Program Management

Education

Advanced degree (PhD/PharmD)

Job description

BioPharma seeks an Associate Director of Medical Writing to provide strategic and operational leadership for medical writing across clinical programs. The role combines hands-on writing with resource planning and matrix leadership to deliver high-quality regulatory documents aligned with program goals.

The ideal candidate will have an advanced degree and 8+ years in medical writing or related areas, with experience supporting NDA/BLA/MAA and IND submissions, and a proven ability to manage